ASTM F1670 F1670M-2017 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood《防护服材料抗人工合成血渗透的标准试验方法》.pdf

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1、Designation: F1670/F1670M 08 (Reapproved 2014)1F1670/F1670M 17Standard Test Method forResistance of Materials Used in Protective Clothing toPenetration by Synthetic Blood1This standard is issued under the fixed designation F1670/F1670M; the number immediately following the designation indicates the

2、yearof original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval.A superscript epsilon () indicates an editorial change since the last revision or reapproval.1 NOTEUnits information was editorially corrected in June 2014.I

3、NTRODUCTIONWorkers, primarily those in the health care healthcare profession, involved in treating and caring forindividuals injured or sick, can be exposed to biological liquids capable of transmitting disease. Thesediseases, which may be caused by a variety of microorganisms, can pose significant

4、risks to life andhealth. This is especially true of blood-borne, Hepatitis Hepatitis B Virusblood-borne hepatitis(hepatitis B virus (HBV) and Hepatitishepatitis C Virus (HCV) and Acquired Immune DeficiencySyndrome (AIDS) Human Immunodeficiency Viruses (HIV).virus (HCV) and acquired immunedeficiency

5、syndrome (AIDS) (human immunodeficiency viruses (HIV). Since engineering controlscan not eliminate all possible exposures, attention is placed on reducing the potential of direct skincontact through the use of protective clothing that resists penetration (29 CFR Part 1910.1030). Thistest method was

6、developed to help assess the effectiveness of materials used in protective clothing forprotecting the wearer against contact with body fluids that potentially contain blood-borne pathogens.Using synthetic blood, this test method is intended to identify protective clothing material candidatesfor furt

7、her testing according to a more rigorous procedure involving a surrogate for blood-bornepathogens.1. Scope1.1 This test method is used to evaluate the resistance of materials used in protective clothing to penetration by synthetic bloodunder conditions of continuous liquid contact. Protective clothi

8、ng pass/fail determinations are based on visual detection ofsynthetic blood penetration.1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readilyabsorb the synthetic blood.1.2 This test method is a means for selecting protective

9、clothing materials for subsequent testing with a more sophisticatedbarrier test as described in Test Method F1671.1.3 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method mustreview modes for work/clothing exposure and assess the appro

10、priateness of this test method for their specific application.1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) usedin protective clothing. This test method does not address the design, overall construction and components, or inte

11、rfaces ofgarments, or other factors which may affect the overall protection offered by the protective clothing.1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in eachsystem may not be exact equivalents; therefore, each system

12、shall be used independently of the other. Combining values from thetwo systems may result in non-conformancenonconformance with the standard.1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard

13、 to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.1 This test method is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of SubcommitteeF23.40 on Biolo

14、gical.Current edition approved June 15, 2014July 1, 2017. Published June 2014July 2017. Originally approved in 1995. Last previous edition approved in 20082014 asF1670 08.F1670/F1670M 08 (2014)1. DOI: 10.1520/F1670_F1670M-08R14E01.10.1520/F1670_F1670M-17.This document is not an ASTM standard and is

15、intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the c

16、urrent versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States11.7 This international standard was developed in accordance with internationally recognized p

17、rinciples on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D1331 Test Methods for Surface

18、 and Interfacial Tension of Solutions of Paints, Solvents, Solutions of Surface-Active Agents,and Related MaterialsD1777 Test Method for Thickness of Textile MaterialsD3776 Test Methods for Mass Per Unit Area (Weight) of FabricE105 Practice for Probability Sampling of MaterialsE171 Practice for Cond

19、itioning and Testing Flexible Barrier PackagingF903 Test Method for Resistance of Materials Used in Protective Clothing to Penetration by LiquidsF1671 Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens UsingPhi-X174 Bacteriophage Penetration a

20、s a Test System2.2 Military Standard:3MIL-STD-105 Sampling Procedures and Tables for Inspection by Attributes2.3 ANSI/ASQC Standards:4ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes2.4 ISO Standard:5ISO 2859-1 Sampling Plans for Inspection by Attributes2.5 OSHA Standard:62

21、9 CFR Part 1910.1030 CFR Part 1910.1030 Occupational Exposure to Blood-borneBlood-Borne Pathogens: Final Rule,Federal RegisterVol 56, No 235, Dec. 6, 1991, pp. 617564182.6175641823. Terminology3.1 blood-borne pathogen, nan infectious secreted or excreted bacterium, virus, or other disease inducing d

22、isease-inducingmicrobe carried in blood or other body fluids.3.2 body fluid, nany liquid produced, secreted, or excreted by the human body.3.2.1 DiscussionIn this test method, body fluids include those liquids potentially infected with blood-borne pathogens, including, but not limitedto, blood, seme

23、n, vaginal secretions, cerebrospinal fluid, synovial fluid and peritoneal fluid, amniotic fluid, saliva in dentalprocedures, and any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult orimpossible to differentiate between body fluids.fluids (s

24、ee 29 CFR Part 1910.1030).3.3 body fluid simulant, na liquid which is used to act as a model for human body fluids.3.3.1 DiscussionIn this test method, synthetic blood is used as a body fluid simulant.3.4 penetration, nthe movement of matter through closures, porous materials, seams, and pinholes or

25、 other imperfections inprotective clothing on a nonmolecular level.3.4.1 DiscussionFor this test method, the specific matter is synthetic blood.3.4.2 Discussion2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of

26、ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.4 Available from American Society for Quality Control, 611 E. Wiscon

27、sin Ave., Milwaukee, WI 53202.5 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.6 Available from Supt. of Documents, U.S. Government Printing Office, Washington, DC 20402.F1670/F1670M 172In this test method, the penetrati

28、on liquid is synthetic blood.3.5 protective clothing, nan item of clothing that is specifically designed and constructed for the intended purpose of isolatingall or part of the body from a potential hazard; or, isolating the external environment from contamination by the wearer of theclothing.3.5.1

29、DiscussionThe potential hazard is contact with blood.3.6 synthetic blood, na mixture of a red dye/surfactant, thickening agent, and distilled water having a surface tension andviscosity representative of blood and some other body fluids, and the color of blood.3.6.1 DiscussionThe synthetic blood in

30、this test method does not simulate all of the characteristics of real blood or body fluids, for example, polarity(a wetting characteristic), coagulation, content of cell matter.4. Summary of Test Method4.1 A specimen is subjected to a body fluid simulant (synthetic blood) for a specified time and pr

31、essure.4.2 Visual observation is made to determine when, or if, penetration occurs.4.3 Any evidence of synthetic blood penetration constitutes failure. Results are reported as pass/fail.5. Significance and Use5.1 This test method is based on Test Method F903 for measuring resistance of chemical prot

32、ective clothing materials topenetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protectiveclothing and individual samples of materials that are candidates for items of protective clothing.5.1.1 Finished items of protective clothing includ

33、e gloves, arm shields, aprons, gowns, coveralls, hoods, and boots.5.1.2 The phrase “specimens from finished items” encompasses seamed and other discontinuous regions as well as the usualcontinuous regions of protective clothing items.5.2 Medical protective clothing materials are intended to be a bar

34、rier to blood, body fluids, and other potentially infectiousmaterials. Many factors can affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, andpolarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the mater

35、ials. The surface tensionrange for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m (1).7 To help simulate the wettingcharacteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of thissurface tension range

36、. The resulting surface tension of the synthetic blood is approximately 0.042 6 0.002 N/m.5.3 The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flowcharacteristics of blood.5.4 Part of the protocol in ProcedureProceduresAand B in

37、 Table 1 for exposing the protective clothing material specimens withsynthetic blood involves pressurization of the test cell to 13.8 kPa 13.8 kPa 2 psig.This hydrostatic pressure has been documentedto discriminate between protective clothing material performance and to correlate with visual penetra

38、tion results that are obtainedwith a human factors validation (2). Some studies, however, suggest that mechanical pressures exceeding 345 kPa 50 psig canoccur during clinical use (3, 4). Therefore, it is important to understand that this test method does not simulate all the physicalstresses and pre

39、ssures that are exerted on protective clothing garments during actual use. This test method is offered to identifythose protective clothing materials that warrant further evaluation with a microbiological challenge.7 The boldface numbers in parentheses refer to the list of references at the end of t

40、his standard.TABLE 1 Specimen Exposure ProceduresProcedure Pressure/Time Sequence and Retaining Screen OptionsA 0 kPa 0 psig for 5 min, followed by 13.8 kPa 2 psig for 1min, followed by 0 kPa 0 psig for 54 min.A retaining screen is not used to support the sample.B 0 kPa 0 psig for 5 min, followed by

41、 13.8 kPa 2 psig for 1min, followed by 0 kPa 0 psig for 54 min.A retaining screen is used to support the sample. The typemust be specified in the report.F1670/F1670M 1735.5 Since this test method uses visual observation rather than analytical measurements for determination of penetration, use thiste

42、st method as a preliminary evaluation for possible penetration of blood and other body fluids. Perform subsequent testing witha microbiological challenge and analytical technique using Test Method F1671.NOTE 1No viral resistance claims can be made based on this test method, as materials can pass the

43、 test method and fail Test Method F1671.5.6 Testing without considering degradation by physical, chemical, and thermal stresses which could negatively impact theperformance of the protective barrier,barrier could lead to a false sense of security. Consider tests which assess the impact ofstorage con

44、ditions and shelf life for disposable products, and the effects of laundering and sterilization for reusable products. Theintegrity of the protective barrier can also be compromised during use by such effects as flexing and abrasion (5). It is also possiblethat prewetting by contaminating materials

45、such as alcohol and perspiration can also compromise the integrity of the protectivebarrier. If these conditions are of concern, evaluate the performance of protective clothing materials for synthetic blood penetrationfollowing an appropriate preconditioning technique representative of the expected

46、conditions of use.5.7 While this test method involves a qualitative determination of the protective clothing material resistance to penetration bysynthetic blood under specific test conditions, it is possible to use this test method as a material quality control or assuranceprocedure.5.7.1 If this p

47、rocedure is used for quality control, perform proper statistical design and analysis of the data,data when more thanthree specimens are tested. This type of analysis includes, but is not limited to, the number of individual specimens tested, theaverage percent passing or failing, or both, with a sta

48、ndard deviation. Data reported in this way helps to establish confidence limitsconcerning product performance. Examples of acceptable sampling plans are found in references such as MIL-STD-105,ANSI/ASQC Z1.4, and ISO 2859-1.6. Apparatus6.1 Thickness Gauge, suitable for measuring thickness to the nea

49、rest 0.02 mm or nearest 0.001 in., in accordance with TestMethod D1777 (Optional).(optional).88 Thickness of each protective clothing material specimen tested may be determined prior to performing the test procedure, but is not required to comply with this testmethod. The thickness data for the material may be available from the manufacturer.FIG. 1 Exploded View of the Penetration Test Cell with Retaining ScreenF1670/F1670M 1746.2 Penetration Test Cell,9, to restrain the specimen during contact with the pressurized test synthetic b